BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 3223106 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-15945
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-07262012-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT REPORTED HE WAS NO LONGER RECEIVING STIMULATION AND WAS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. ALSO, THE PT IS RECEIVING AN IPG COMM ERROR 2501 MESSAGE FROM HIS PT PROGRAMMER. THE PT INDICATED HE HAD NOT CHARGED HIS IPG IN APPROXIMATELY 3 MONTHS. FOLLOW-UP INFORMATION INDICATED THE PT PLANS TO CONSULT WITH HIS PHYSICIAN REGARDING UNDERGOING SURGICAL INTERVENTION AT A LATER DATE TO ADDRESS THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314570 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3371405

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR IMPLANT DATE:| SCS EXTENSION: MODEL: 3386| IMPLANT DATE:| SCS LEAD: MODEL: 3244